Medicines are an important part of everyday life, making it possible for millions of Americans to lead more productive, healthier lives. Fortunately, today there are more than 10,000 prescription medicines available to patients -- each of them holding potential benefits and risks.
The purpose of this document is to answer the most frequently asked questions about drug safety.
Pharmaceutical manufacturers are dedicated to educating the public about drug safety. In addition, the companies are committed to:
No. However, on rare occasions, negative side effects for a particular drug may become apparent after it’s been approved for the general population and large numbers of patients begin using it. In those cases, the FDA and pharmaceutical companies work together to educate the public about those risks and, on rare occasions, remove the medicine from the marketplace.
Patients can be confident that the drug they are taking has been thoroughly studied and evaluated in a series of clinical trials before the FDA approved it for the public. Nevertheless, there are some important steps patients should take to make sure their medicines are safe for them:
The FDA serves as a consumer watchdog—it makes sure that safe and effective drugs are available to improve the health of patients who need them. The FDA evaluates new drugs before they can be sold and ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks. The FDA’s review of new drug applications not only prevents unsafe drugs from entering the market, but it provides doctors and patients with the...
The pharmaceutical industry has two major roles in managing the safety of medicines:
In...
No drug is 100% safe and effective for all patients. Every drug, whether it is over-the-counter or prescription, carries some risks, or potential side effects, and sometimes these side effects don’t become known until after the medicine has been made available to the general patient population. Therefore, manufacturers and FDA collaborate on long-term follow-up studies and physicians, nurses, and patients are urged to report any unusual side effect experienced while taking medication.
Pharmaceutical companies, the FDA, health care providers and patients all play important roles in monitoring drug safety. Once a new medicine is approved, the manufacturer is required to file safety reports with FDA every three months for three years, and then annually for as long as the drug is marketed. Serious and unexpected adverse events must be reported to FDA within 15 days.
In addition, FDA may request a series of long-term, follow-up studies on the medicine. The companies have...
Drug safety is established incrementally through all stages of the development process. It is assessed early in the process through a series of laboratory tests, animal tests, and then with very small numbers of volunteer patients. Only after it’s clear that a drug is safe for people will it be tested in larger numbers of individuals in carefully controlled, monitored studies known as “clinical trials” to assess both safety and efficacy. These studies, which are evaluated by the FDA and overseen by...
There are more than 3.6 billion prescriptions written per year in the U.S. and for the overwhelming majority of patients, those medicines have proven to be safe and effective. According to the Food and Drug Administration (FDA), about 97% of the drugs it has approved over the past two decades are still on the market and considered safe. America’s pharmaceutical companies, while pleased with this performance, continue to...
